Trial information
A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.
Status: Recruiting
Protocol number: BO20571
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study comparing the anti-tumor effect of treatment with Tarceva plus Avastin versus chemotherapy plus Avastin in patients with advanced non-small cell lung cancer
Brief summary: This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is
200.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: erlotinib [Tarceva]
Primary outcome: 1. Progression-free survival Time frame: Event driven
Key secondary outcomes: 1. Survival, best response, disease control. Time frame: Event driven
2. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- advanced (stage IIIb and IV) non-small cell lung cancer;
- measurable disease;
- ECOG PS 0-1.
Exclusion criteria:
- prior chemotherapy or treatment with another systemic anti-cancer agent;
- radiotherapy within 4 weeks prior to first dose of study treatment;
- CNS metastases;
- other malignancies in past 5 years, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2008
Trial registration date: 09/17/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
Belgium
France
- Bayonne
- Dijon
- Le Mans
- Marseille
- Paris
- Strasbourg
- Vandoeuvre-Les-Nancy
Italy
- Ancona
- Aviano
- Lido Di Camaiore
- Milano
Korea, Republic of
- Daegu
- Incheon
- Kyunggi Do
- Seoul
- Sungham
- Suwon
Lithuania
Netherlands
- Amsterdam
- Eindhoven
- Groningen
- Heerlen
- Maastricht
- Rotterdam
- 'S Hertogenbosch
Poland
Romania
- Bucharest
- Cluj-Napoca
- Timisoara
Singapore
Spain
- Alicante
- Barcelona
- La Coruna
- Madrid
- Malaga
- Sevilla
Taiwan
- Changhua
- Kaohsiung
- Tainan
- Taipei
- Taoyuan
United Kingdom
- Dudley
- Guildford
- Manchester
